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Stopwatch-measured IELT was reported in seven publications listed in Table 2, with the duration of these studies ranging from 9 to 24 weeks. Mean average IELT was significantly increased in all cases following treatment with dapoxetine 30 mg or 60 mg, with end-of-study values being significantly greater than those for placebo, indicating an improvement in PE.

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The RCT by McMahon et al demonstrated significant increases from baseline in mean (± standard deviation) IELT after just one dose of dapoxetine, ie, 30 mg (1.1 [0.45]–2.7 [2.68] minutes), 60 mg (1.1 [0.48]– 3.0 [3.19] minutes), and placebo (1.0 [0.47]–1.8 [1.71]; P < 0.001) for both doses of dapoxetine vs placebo.44 This significant difference from placebo was evident at all time points to the end of the study.

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Of the seven studies in Table 2, four reported arithmetic and geometric means of average IELT, while three reported only one or the other. Geometric means give more conservative results that are less affected by data outliers, thus the values tend to be lower than those for arithmetic means. Where both geometric and arithmetic means were presented, the results for average IELT were similar for both methods. For example, in the integrated analysis of five Phase III studies, geometric mean IELT increased from 0.8 minutes at baseline in all groups to 2.0 and 2.3 minutes in those taking dapoxetine 30 mg and 60 mg, respectively, compared with 1.3 minutes for those taking placebo (both P < 0.001).45 The corresponding arithmetic means increased from 0.9 minutes at baseline to 3.1, 3.6, and 1.9 minutes, respectively (both P < 0.001 vs placebo, Table 2). Even in more extreme cases of PE, in which baseline IELT was very short, treatment with dapoxetine effectively increased IELT. In the integrated analysis of two Phase III studies by Pryor et al,46 increases from baseline in average IELT at 12 weeks were significantly greater for either dose of dapoxetine (30 mg or 60 mg) than for placebo in the subgroups of patients with baseline average IELTs ≤1 minute and ≤30 seconds.

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Stopwatch-measured IELT was reported in seven publications listed in Table 2, with the duration of these studies ranging from 9 to 24 weeks. Mean average IELT was significantly increased in all cases following treatment with dapoxetine 30 mg or 60 mg, with end-of-study values being significantly greater than those for placebo, indicating an improvement in PE. The RCT by McMahon et al demonstrated significant increases from baseline in mean (± standard deviation) IELT after just one dose of dapoxetine, ie, 30 mg (1.1 [0.45]–2.7 [2.68] minutes), 60 mg (1.1 [0.48]– 3.0 [3.19] minutes), and placebo (1.0 [0.47]–1.8 [1.71]; P < 0.001) for both doses of dapoxetine vs placebo.44 This significant difference from placebo was evident at all time points to the end of the study. Of the seven studies in Table 2, four reported arithmetic and geometric means of average IELT, while three reported only one or the other. Geometric means give more conservative results that are less affected by data outliers, thus the values tend to be lower than those for arithmetic means.

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Where both geometric and arithmetic means were presented, the results for average IELT were similar for both methods. For example, in the integrated analysis of five Phase III studies, geometric mean IELT increased from 0.8 minutes at baseline in all groups to 2.0 and 2.3 minutes in those taking dapoxetine 30 mg and 60 mg, respectively, compared with 1.3 minutes for those taking placebo (both P < 0.001).45 The corresponding arithmetic means increased from 0.9 minutes at baseline to 3.1, 3.6, and 1.9 minutes, respectively (both P < 0.001 vs placebo, Table 2). Even in more extreme cases of PE, in which baseline IELT was very short, treatment with dapoxetine effectively increased IELT. In the integrated analysis of two Phase III studies by Pryor et al,46 increases from baseline in average IELT at 12 weeks were significantly greater for either dose of dapoxetine (30 mg or 60 mg) than for placebo in the subgroups of patients with baseline average IELTs ≤1 minute and ≤30 seconds. The subanalysis of these studies by Shabsigh et al49 highlighted the importance of perceived control over ejaculation for achieving increases in IELT.

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Patients who reported at least a two-category improvement in control after 12 weeks of dapoxetine therapy recorded a mean change in IELT of 3.8 (0.9–4.7) minutes, whereas those who reported less than a two-category improvement in control recorded a mean change in IELT of 0.8 (0.9–1.7) minutes (Table 2). Overall, the consistent nature of the results from the studies identified indicates substantial evidence for a significant increase in IELT with dapoxetine 30 mg and 60 mg, compared with placebo, in adult patients with PE. In studies of PE, patient-reported outcomes form an important part of the evidence base because of the many ways in which PE can affect psychological wellbeing and quality of life, both for the patient and their sexual partner. The most frequently applied instrument in studies of PE is the Premature Ejaculation Profile, which is a validated tool designed to investigate various domains in PE and assess treatment efficacy. It comprises four self-reported items, each scored on a five-point scale, ie, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation.50 In addition, the Clinical Global Impression (CGI) of change is a validated instrument often used to give a measurement of overall perceived change in PE following treatment. The subanalysis of these studies by Shabsigh et al49 highlighted the importance of perceived control over ejaculation for achieving increases in IELT. Patients who reported at least a two-category improvement in control after 12 weeks of dapoxetine therapy recorded a mean change in IELT of 3.8 (0.9–4.7) minutes, whereas those who reported less than a two-category improvement in control recorded a mean change in IELT of 0.8 (0.9–1.7) minutes (Table 2). Overall, the consistent nature of the results from the studies identified indicates substantial evidence for a significant increase in IELT with dapoxetine 30 mg and 60 mg, compared with placebo, in adult patients with PE.

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In studies of PE, patient-reported outcomes form an important part of the evidence base because of the many ways in which PE can affect psychological wellbeing and quality of life, both for the patient and their sexual partner. The most frequently applied instrument in studies of PE is the Premature Ejaculation Profile, which is a validated tool designed to investigate various domains in PE and assess treatment efficacy. It comprises four self-reported items, each scored on a five-point scale, ie, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation.50 In addition, the Clinical Global Impression (CGI) of change is a validated instrument often used to give a measurement of overall perceived change in PE following treatment.

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The role of tyrosine hydroxylase within dapoxetine-assisted therapy against premature ejaculation

The CGI (also called the patient-reported global impression of change in some studies) comprises just one item, ie, “Compared to the start of the study, how would you describe your premature ejaculation now?” Patients rate their response on a seven-point scale (−3 to +3) as: much worse, worse, slightly worse, no change, slightly better, better, or much better.51 Studies reporting patient responses to items on the Premature Ejaculation Profile and the CGI of change are listed in Table 2, with quality of evidence indications. Each dapoxetine viagra of the patient-reported outcomes is assessed individually below. Changes from baseline in perceived control over ejaculation are reported for eight studies (Table 3). All three integrated analyses found significant improvements in control over ejaculation at study endpoint. In McMahon et al, in which the results from five RCTs were integrated, the proportion of patients who reported at least “good” control after 12 weeks of dapoxetine therapy increased from a baseline of 0.6% to 26.2% with dapoxetine 30 mg, and from 0.5% to 30.2% with dapoxetine 60 mg, compared with 0.3% to 11.2% with placebo (P < 0.001 for both dapoxetine doses vs placebo).45 Note: Only data for patients without erectile dysfunction are shown for consistency with other studies. Abbreviations: CGI, Clinical Global Impression; NR, not reported; RCT, randomized, placebo-controlled trial; PBO, placebo; DPX, dapoxetine.

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The CGI (also called the patient-reported global impression of change in some studies) comprises just one item, ie, “Compared to the start of the study, how would you describe your premature ejaculation now?” Patients rate their response on a seven-point scale (−3 to +3) as: much worse, worse, slightly worse, no change, slightly better, better, or much better.51 Studies reporting patient responses to items on the Premature Ejaculation Profile and the CGI of change are listed in Table 2, with quality of evidence indications. Each dapoxetine viagra of the patient-reported outcomes is assessed individually below. Changes from baseline in perceived control over ejaculation are reported for eight studies (Table 3). All three integrated analyses found significant improvements in control over ejaculation at study endpoint. In McMahon et al, in which the results from five RCTs were integrated, the proportion of patients who reported at least “good” control after 12 weeks of dapoxetine therapy increased from a baseline of 0.6% to 26.2% with dapoxetine 30 mg, and from 0.5% to 30.2% with dapoxetine 60 mg, compared with 0.3% to 11.2% with placebo (P < 0.001 for both dapoxetine doses vs placebo).45 Note: Only data for patients without erectile dysfunction are shown for consistency with other studies.

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Abbreviations: CGI, Clinical Global Impression; NR, not reported; RCT, randomized, placebo-controlled trial; PBO, placebo; DPX, dapoxetine. The integrated analysis by Porst et al of two studies showed no differences in control over ejaculation between those with lifelong or acquired PE (and no erectile dysfunction), suggesting that the etiology of the two forms may be similar, given that dapoxetine treatment was equally effective.47 The proportions of patients reporting at least “good” control at baseline and end-of-study were as follows: Acquired PE, 1% at baseline to 32% at end-of-study (dapoxetine 30 mg); 1% to 35% (dapoxetine 60 mg), and 1% to 19% (placebo) Acquired PE, 1% at baseline to 32% at end-of-study (dapoxetine 30 mg); 1% to 35% (dapoxetine 60 mg), and 1% to 19% (placebo) Lifelong PE, 0.5% at baseline to 29% at end-of-study (dapoxetine 30 mg); 0.5% to 28% (dapoxetine 60 mg), and 0.5% to 12% (placebo)47 Lifelong PE, 0.5% at baseline to 29% at end-of-study (dapoxetine 30 mg); 0.5% to 28% (dapoxetine 60 mg), and 0.5% to 12% (placebo)47 Significant improvement in ejaculatory control with dapoxetine 30 mg or 60 mg, as compared with placebo, was found in all RCTs in Table 3. These improvements were noted not only at the end-of-study but at all time points in between.44,47,52 The long-term use of on-demand dapoxetine has been addressed in just one study (see Table 3), ie, a 9-month extension study of the two 12-week trials described by Pryor et al.47 All of the 1774 men enrolled in the extension study received on-demand dapoxetine 60 mg, regardless of prior treatment group in the original studies (dapoxetine 30 mg, 60 mg, or placebo). At 9 months, approximately 70% of patients reported “fair”, “good”, or “very good” control over ejaculation.53 These data represent clear evidence of a significant improvement over placebo in perceived control over ejaculation in adult patients with PE taking dapoxetine 30 mg or 60 mg on-demand. Changes from baseline in satisfaction with sexual intercourse were reported in eight studies (Table 3).

Psychological Factors and Treatment Outcomes

All three integrated analyses found significant improvements in satisfaction with sexual intercourse at study endpoint. In the analysis of two 12-week studies by Pryor et al, the proportion of patients receiving dapoxetine who reported at least “fair” satisfaction increased from approximately 50% at baseline to approximately 75% (dapoxetine 30 mg) and 80% (dapoxetine 60 mg) at end-of-study, compared with approximately 55% with placebo (P < 0.001 for both dapoxetine doses vs placebo; data estimated from Pryor et al).47 Furthermore, significant differences from baseline were seen at every time point for both doses of dapoxetine vs placebo (weeks 4, 8, and 12). Importantly, the partners of subjects in these trials also reported significant improvements in satisfaction with sexual intercourse at every time point, suggesting possible associated reductions in interpersonal difficulty (not measured in these studies). This integrated analysis also found a dose-dependent effect of dapoxetine, with significantly more patients on dapoxetine 60 mg reporting at least “fair” satisfaction at every time point compared with those on dapoxetine 30 mg.47 Subanalysis of the trials published by Shabsigh et al highlighted the impact of greater perceived control over ejaculation on other aspects of sexual experience, with 74% of patients having at least a two-category increase in control-rated satisfaction with intercourse of “good” or “very good” at end-of-study.49 The integrated analysis of two studies by Porst et al showed no differences in satisfaction with intercourse between those with lifelong or acquired PE (no erectile dysfunction), indicating that the two forms potentially share some pathophysiological elements.47 The proportions of patients reporting at least “good” satisfaction with intercourse at baseline and end-of-study (pooled 12-week data from a 12-week and a 24-week study) were as follows: Acquired PE, 7% at baseline to 38% at end-of-study (dapoxetine 30 mg); 7% to 42% (dapoxetine 60 mg) and 7% to 29% (placebo) Acquired PE, 7% at baseline to 38% at end-of-study (dapoxetine 30 mg); 7% to 42% (dapoxetine 60 mg) and 7% to 29% (placebo) Life-long PE, 10% at baseline to 40% at end-of-study (dapoxetine 30 mg); 10% to 38% (dapoxetine 60 mg) and 10% to 23% (placebo) Life-long PE, 10% at baseline to 40% at end-of-study (dapoxetine 30 mg); 10% to 38% (dapoxetine 60 mg) and 10% to 23% (placebo) All three of the RCTs in Table 3 found significant improvements from baseline in satisfaction with intercourse compared with placebo at end-of-study and at all time points in between. For example, at end of the McMahon et al study, the proportions of patients who reported “good” or “very good” satisfaction with intercourse were 41.3% for dapoxetine 30 mg, 40.9% for dapoxetine 60 mg, and 29.0% for placebo (P < 0.001 for both doses of dapoxetine vs placebo).44 The effect of long-term dapoxetine treatment on satisfaction with sexual intercourse was examined in the nonrandomized extension study by Steidle et al (see Table 3).54 Irrespective of prior treatment (dapoxetine 30 mg, 60 mg, or placebo), long-term on-demand use of dapoxetine 60 mg resulted in more than 80% of patients reporting at least “fair” satisfaction with intercourse after 9 months.54 There is clear evidence from these studies that dapoxetine therapy in adult males with PE improves satisfaction with sexual intercourse in comparison with placebo. The integrated analysis by Porst et al of two studies showed no differences in control over ejaculation between those with lifelong or acquired PE (and no erectile dysfunction), suggesting that the etiology of the two forms may be similar, given that dapoxetine treatment was equally effective.47 The proportions of patients reporting at least “good” control at baseline and end-of-study were as follows: Acquired PE, 1% at baseline to 32% at end-of-study (dapoxetine 30 mg); 1% to 35% (dapoxetine 60 mg), and 1% to 19% (placebo) Acquired PE, 1% at baseline to 32% at end-of-study (dapoxetine 30 mg); 1% to 35% (dapoxetine 60 mg), and 1% to 19% (placebo) Lifelong PE, 0.5% at baseline to 29% at end-of-study (dapoxetine 30 mg); 0.5% to 28% (dapoxetine 60 mg), and 0.5% to 12% (placebo)47 Lifelong PE, 0.5% at baseline to 29% at end-of-study (dapoxetine 30 mg); 0.5% to 28% (dapoxetine 60 mg), and 0.5% to 12% (placebo)47 Significant improvement in ejaculatory control with dapoxetine 30 mg or 60 mg, as compared with placebo, was found in all RCTs in Table 3.

  • Future treatments may offer alternatives to Viagra with Dapoxetine.
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These improvements were noted not only at the end-of-study but at all time points in between.44,47,52 The long-term use of on-demand dapoxetine has been addressed in just one study (see Table 3), ie, a 9-month extension study of the two 12-week trials described by Pryor et al.47 All of the 1774 men enrolled in the extension study received on-demand dapoxetine 60 mg, regardless of prior treatment group in the original studies (dapoxetine 30 mg, 60 mg, or placebo).

Reviewer Effectiveness Side Effects Satisfaction Level Comments
User A Very effective Mild headache 5/5 Works well for both ED and PE
User B Moderately effective Dizziness 4/5 Slight dizziness but manageable
User C Less effective None reported 3/5 Needs higher dose for better results
User D Effective Nausea at start 4/5 Side effects decrease over time

At 9 months, approximately 70% of patients reported “fair”, “good”, or “very good” control over ejaculation.53 These data represent clear evidence of a significant improvement over placebo in perceived control over ejaculation in adult patients with PE taking dapoxetine 30 mg or 60 mg on-demand.

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Changes from baseline in satisfaction with sexual intercourse were reported in eight studies (Table 3).

  • Viagra with Dapoxetine is not recommended for women or children.
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All three integrated analyses found significant improvements in satisfaction with sexual intercourse at study endpoint. In the analysis of two 12-week studies by Pryor et al, the proportion of patients receiving dapoxetine who reported at least “fair” satisfaction increased from approximately 50% at baseline to approximately 75% (dapoxetine 30 mg) and 80% (dapoxetine 60 mg) at end-of-study, compared with approximately 55% with placebo (P < 0.001 for both dapoxetine doses vs placebo; data estimated from Pryor et al).47 Furthermore, significant differences from baseline were seen at every time point for both doses of dapoxetine vs placebo (weeks 4, 8, and 12). Importantly, the partners of subjects in these trials also reported significant improvements in satisfaction with sexual intercourse at every time point, suggesting possible associated reductions in interpersonal difficulty (not measured in these studies).

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This integrated analysis also found a dose-dependent effect of dapoxetine, with significantly more patients on dapoxetine 60 mg reporting at least “fair” satisfaction at every time point compared with those on dapoxetine 30 mg.47 Subanalysis of the trials published by Shabsigh et al highlighted the impact of greater perceived control over ejaculation on other aspects of sexual experience, with 74% of patients having at least a two-category increase in control-rated satisfaction with intercourse of “good” or “very good” at end-of-study.49 The integrated analysis of two studies by Porst et al showed no differences in satisfaction with intercourse between those with lifelong or acquired PE (no erectile dysfunction), indicating that the two forms potentially share some pathophysiological elements.47 The proportions of patients reporting at least “good” satisfaction with intercourse at baseline and end-of-study (pooled 12-week data from a 12-week and a 24-week study) were as follows: Acquired PE, 7% at baseline to 38% at end-of-study (dapoxetine 30 mg); 7% to 42% (dapoxetine 60 mg) and 7% to 29% (placebo) Acquired PE, 7% at baseline to 38% at end-of-study (dapoxetine 30 mg); 7% to 42% (dapoxetine 60 mg) and 7% to 29% (placebo) Life-long PE, 10% at baseline to 40% at end-of-study (dapoxetine 30 mg); 10% to 38% (dapoxetine 60 mg) and 10% to 23% (placebo) Life-long PE, 10% at baseline to 40% at end-of-study (dapoxetine 30 mg); 10% to 38% (dapoxetine 60 mg) and 10% to 23% (placebo) All three of the RCTs in Table 3 found significant improvements from baseline in satisfaction with intercourse compared with placebo at end-of-study and at all time points in between.

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For example, at end of the McMahon et al study, the proportions of patients who reported “good” or “very good” satisfaction with intercourse were 41.3% for dapoxetine 30 mg, 40.9% for dapoxetine 60 mg, and 29.0% for placebo (P < 0.001 for both doses of dapoxetine vs placebo).44 The effect of long-term dapoxetine treatment on satisfaction with sexual intercourse was examined in the nonrandomized extension study by Steidle et al (see Table 3).54 Irrespective of prior treatment (dapoxetine 30 mg, 60 mg, or placebo), long-term on-demand use of dapoxetine 60 mg resulted in more than 80% of patients reporting at least “fair” satisfaction with intercourse after 9 months.54 There is clear evidence from these studies that dapoxetine therapy in adult males with PE improves satisfaction with sexual intercourse in comparison with placebo.